BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSTELLATION WITH LASER

    MDR report key: 2023663 · Received March 3, 2011

    Report

    Report Number
    2028159-2011-00193
    Event Type
    Other
    Date Received
    March 3, 2011
    Report Date
    January 25, 2011
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K063583
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    UNKNOWN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPRESENTATIVE EXAMINED THE SYSTEM AND FOUND TO BE WITHIN SPECIFICATIONS; THE PNEUMATIC MODULE WAS REPLACED AS PRECAUTIONARY. THE SYSTEM WAS THEN TESTED AND FOUND TO MEET ALL PRODUCT SPECIFICATIONS. THE PNEUMATIC MODULE IS RETURNING FOR EVALUATION. INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL REPORTABLE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED INTERMITTENT VACUUM ISSUES. ADDITIONAL INFORMATION WAS RECEIVED INDICATING THE REPORTED EVENT OCCURRED DURING SURGERY. THE SYSTEM WAS SWITCHED OUT AND THE CASE WAS COMPLETED. A COMPLETED QUESTIONNAIRE WAS RECEIVED REPORTING THERE WAS PRESSURE FLUCTUATION WHILE PERFORMING FLUID/AIR EXCHANGE. THERE WAS NO SYSTEM MESSAGE DISPLAYED. THE QUESTIONNAIRE ALSO NOTED THAT THE PATIENT HAD CHOROIDALS THAT HAVE SINCE RESOLVED. THE PATIENT'S OUTCOME WAS REPORTED AS "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSTELLATION WITH LASER UNIT, PHACOFRAGMENTATION HQC ALCON - IRVINE TECHNOLOGY CENTER CONSTELLATION NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other